BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM PUTTY

    MDR report key: 2190984 · Received July 29, 2011

    Report

    Report Number
    2246640-2011-00013
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    March 18, 2011
    Report Date
    July 11, 2011
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    NUN
    PMA / PMN Number
    K051188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL DONOR AND MANUFACTURING RECORDS RELATIVE TO THE SUBJECT GRAFT WERE REVIEWED BY OSTEOTECH'S MEDICAL DIRECTOR, AND INDICATED THAT THE GRAFT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL SPECIFICATIONS. STERILITY RESULTS WERE NEGATIVE. THERE WERE NO DEFICIENCIES, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THIS GRAFT. DONOR SUITABILITY RECORDS WERE REVIEWED AND THE TISSUE WAS DEEMED SUITABLE FOR PROCESSING AND FOR TRANSPLANTATION OUTSIDE OF THE UNITED STATES. THE DONOR TISSUE WAS PRE-TREATED WITH GAMMA IRRADIATION PRIOR TO PROCESSING. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO OSTEOTECH WAS NOTIFIED OF THIS INCIDENT; NO ADDITIONAL REPORTS OF INFECTION HAVE BEEN RECEIVED INVOLVING ANY OTHER TISSUES PROCURED FROM THIS DONOR. IN ADDITION, OSTEOTECH HAS NOT RECEIVED ANY OTHER REPORTS OF INFECTION INVOLVING ANY OTHER GRAFTS MANUFACTURED FROM THIS DONOR TISSUE. ACCORDING TO THE INITIAL REPORTER, THE OPERATING SURGEON STATED THAT IN HER OPINION, THE SUBJECT GRAFT WAS NOT THE CAUSE OF THE PATIENT'S INFECTION. BASED ON THESE FINDINGS, OSTEOTECH'S MEDICAL DIRECTOR HAS CONCLUDED THAT THERE IS NO EVIDENCE TO INDICATE THAT THE SUBJECT GRAFT CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. NO FURTHER ACTION IS DEEMED NECESSARY. THIS INCIDENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AS REPORTED BY DISTRIBUTOR, ON (B)(6) 2011 THE PATIENT UNDERWENT A LEFT MAXILLARY SINUS ELEVATION USING BOTH AUTOLOGOUS BONE AND ALLOGRAFT BONE VOID FILLER. ON (B)(6) 2011, THE PATIENT PRESENTED WITH SYMPTOMS OF INFECTION AND WAS STARTED ON ANTIBIOTICS. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011. IT IS NOT KNOWN IF THE SUBJECT GRAFT WAS EXPLANTED, AND NO ADDITIONAL TREATMENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON DBM PUTTY DEMINERALIZED BONE MATRIX ALLOGRAFT NUN OSTEOTECH, INC. 1CC OCE713320644070

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R